The clinical evaluation process for medical devices has expanded from a simple process to a comprehensive justification and critical appraisal of its safety and performance. This session will review clinical evaluation requirements and discuss strategies to help you avoid questions from notified bodies- organizations in charge of the conformity assessment of medical devices before they are placed on the market or put into service.
Learning Objectives:
Describe key concepts of applicable regulations and guidance documents related to clinical evaluation
Review common clinical evaluation pitfalls and how to avoid them